CLONAC diclofenac sodium 50 mg modified release tablet blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

diclofenac sodium, Quantity: 50 mg

から入手可能:

Arrotex Pharmaceuticals Pty Ltd

INN（国際名）:

Diclofenac sodium

医薬品形態:

Tablet, enteric coated

構図:

Excipient Ingredients: lactose monohydrate; purified talc; povidone; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; iron oxide red; hypromellose; methacrylic acid - ethyl acrylate copolymer (1:1); triethyl citrate; sodium starch glycollate type A; maize starch; PEG-40 hydrogenated castor oil; magnesium stearate; iron oxide yellow

投与経路:

Oral

パッケージ内のユニット:

10, 20, 50

処方タイプ:

(S4) Prescription Only Medicine

適応症:

Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis and osteoarthritis. Relief of acute or chronic pain states in which there is an,inflammatory component. Symptomatic treatment of primary dysmenorrhoea.

製品概要:

Visual Identification: Round, pale brown, enteric coated tablets, plain on both sides; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

認証ステータス:

Licence status A

承認日:

2017-04-04

情報リーフレット

CLONAC – Consumer Medicine Information
Page 1 of 5
CLONAC
_diclofenac sodium _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CLONAC.
It does not contain all the available
information. It does not take the place
of talking to your doctor or pharmacist.
All medicines have benefits and risks.
Your doctor has weighed the risks of
you taking CLONAC against the
benefits they expect it will have for you.
TALK TO YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY CONCERNS ABOUT TAKING
THIS MEDICINE.
KEEP THIS LEAFLET WITH YOUR MEDICINE.
You may need to read it again.
WHAT CLONAC IS USED
FOR
CLONAC belongs to a family of
medicines called non-steroidal anti-
inflammatory drugs (NSAIDs), which
are used to treat pain and reduce
inflammation (swelling and redness)
that may occur in the following:
•
different types of arthritis including
rheumatoid arthritis and
osteoarthritis
•
other painful conditions where
swelling is a problem such as back
pain, rheumatism, muscle strains,
sprains and tendonitis (eg. tennis
elbow)
•
menstrual cramps (period pain).
These medicines can relieve the
symptoms of pain and inflammation,
but they will not cure your condition.
Your doctor may have prescribed this
medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another purpose.
CLONAC is available only with a
doctor's prescription.
This medicine is not addictive.
BEFORE YOU TAKE IT
_ _
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE CLONAC IF YOU ARE
ALLERGIC (HYPERSENSITIVE) TO:
•
DICLOFENAC (THE ACTIVE INGREDIENT
IN CLONAC) OF ANY OF THE OTHER
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET
•
OTHER MEDICINES CONTAINING
DICLOFENAC
•
ASPIRIN
•
IBUPROFEN
•
ANY OTHER NSAID.
IF YOU ARE NOT SURE IF YOU ARE TAKING
ANY OF THE ABOVE MEDICINES, ASK YOUR
DOCTOR OR PHARMACIST.
Some of the symptoms of an allergic
reaction may include
•
shortness of breath
•
wheezing or difficulty brea

製品の特徴

1
AUSTRALIAN PRODUCT INFORMATION – CLONAC (DICLOFENAC
SODIUM) TABLETS
1
NAME OF THE MEDICINE
Diclofenac sodium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CLONAC tablets are enteric coated and contain either 25 mg or 50 mg of
diclofenac sodium.
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
25 mg Tablets: Pale yellow, round, enteric coated tablets plain on
both sides.
50 mg Tablets: Pale brown, round, enteric coated tablets plain on both
sides
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
Inflammatory and degenerative forms
of
rheumatism:
rheumatoid
arthritis
and
osteoarthritis.
•
Relief of acute or chronic pain states in which there is an
inflammatory component.
•
Symptomatic treatment of primary dysmenorrhoea.
4.2
D
OSE AND METHOD OF ADMINISTRATION
After assessing the risk/benefit ratio in each individual patient, the
lowest effective dose for the
shortest possible duration should be used. Adverse effects may be
minimized by using the lowest
effective dose for the shortest duration necessary to control symptoms
(see Section 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE). Patients on long term treatment
should be reviewed
regularly with regards to efficacy, risk factors and ongoing need for
treatment.
The tablets should be swallowed whole with liquid, preferably before
meals, and must not be divided
or chewed.
2
ADULTS:
Initial dosage is 75 to 150 mg daily. For long-term therapy, 75 to 100
mg daily is usually sufficient.
The daily dosage should generally be prescribed in 2 or 3 divided
doses.
In primary dysmenorrhoea the daily dosage, which should be
individually adapted, is generally 50 to
150 mg. Initially a dose of 50 to 100 mg should be given and, if
necessary, raised in the course of
several menstrual cycles up to a maximum of 200 mg/day. Treatment
should be started upon
appearance of the first symptoms and, depending on the symptomatology,
continued for a few days.
4.3
C
ONTRAINDICATIONS
•
Gastri